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Lung CancerPhase 2EUCROSSNCT02183870

EUCROSS: European Trial on Crizotinib in ROS1 Translocated Lung Cancer

A Phase 2 study testing Crizotinib in people with Lung Cancer and Adenocarcinoma, run by University of Cologne at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated with 250mg crizotinib bid until progression or intolerable toxicity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Adenocarcinoma, NSCLC
What is being tested?
Crizotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
18 sitesin 3 countries
Study dates
May 2014to 29 Feb 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with adenocarcinoma of the lung that is locally advanced or metastatic independent from the number of prior lines of therapy, i.e. including non-pretreated patients (UICC stage IIIB or IV)
  • Positive for ROS1 translocation by central FISH-testing
  • Ability to swallow pills
  • Age > 18 years
  • ECOG performance status 0 to 2
  • Life expectancy of at least 12 weeks
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  • Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
  • Any prior treatment (chemotherapy, radiation or surgery) must have been completed at least 2 weeks prior to initiation of study medication
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to screening:
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,000 /mm3
  • Platelet count ≥ 50 000/µL
  • Total bilirubin ≤ 2 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (AP) ≤ 2,5 x ULN or ≤ 5 x ULN in case of liver involvement
  • PT-INR/PTT ≤ 1.5 x ULN
  • Serum creatinine ≤ 2 times ULN
  • Calculated creatinine clearance (CLcr) ≥ 40 ml/min (Cockcroft-Gault formula)
  • Written informed consent
  • Negative serum pregnancy test within 3 days prior to start of dosing premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
  • Fertile men and women must have an effective method of contraception during treatment and for at least 3 months after completion of treatment as directed by their physician. Effective methods of contraception result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence where lifestyle of the patient ensures compliance (Periodic abstinence and withdrawal are not acceptable methods of contraception).

Who cannot join

  • Previous treatment with specific ALK or ROS1 inhibitors
  • Current treatment within another therapeutic clinical trial
  • Other history of ongoing malignancy that would potentially interfere with the interpretation of efficacy (early stage or chronic disease is allowed if not requiring active therapy or intervention and being under control)
  • Pregnancy or breastfeeding
  • Use of drugs or foods that are known potent CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole and grapefruit or grapefruit juice
  • Use of drugs that are known potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort
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  • Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine
  • Active CNS metastases. Patients with brain metastasis are eligible if asymptomatic for ≥ 14 days before starting study medication and off corticosteroids.
  • History of or known carcinomatous meningitis or leptomeningeal disease
  • Known diagnosis of HIV, active hepatitis B and/or C (testing is not mandatory)
  • Any person being in an institution on assignment of the respective authority against his/her own will
  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
  • Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval > 470ms
  • Patients with known interstitial fibrosis or interstitial lung disease
  • Any of the following within 3 months prior to first crizotinib administration:
  • Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

Spain11 sites

  • Maria Rosaria Garcia Campelo

    A Coruña

  • CEIC Hospital General Universitario de Alicante

    Alicante

  • CEIC Hopsital Vall d'Hebron

    Barcelona

  • Institut Catala D'Oncologia

    Barcelona

  • Hospital Universitario Materno-Infantil de Canarias

    Las Palmas de Gran Canaria

  • CEIC Área 2 - Hospital Universitario de La Princesa

    Madrid

  • CEIC Área 6 - Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda

  • CEIC Malaga Nordeste - Hospital Regional Universitario Carlos Haya

    Málaga

  • Hospital Son Llatzer

    Palma de Mallorca

  • CEIC Hospital Universitario Virgen del Rocio

    Seville

  • CEIC Hospital Clínico Universitario de Valencia

    Valencia

Other trials in Spain

Germany6 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • University of Cologne / LCGC

    Cologne, 50937

  • Universitätsklinikum Frankfurt - Medizinische Klinik II

    Frankfurt a.M., Hesse, 60590

  • LungenClinic Großhansdorf

    Großhansdorf, Schleswig-Holstein, 22927

  • Thoraxklinik Heidelberg

    Heidelberg, Baden-Würtemberg, 69126

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

Switzerland1 site

  • Universitätsspital Basel

    Basel

Other trials in Switzerland

About this study

Official title: EUCROSS: A Phase II Trial to Evaluate Efficacy and Safety of Crizotinib Treatment in Advanced Adenocarcinoma of the Lung Harbouring ROS1 Translocations

EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. Patients will be treated with 250mg crizotinib bid until progression or intolerable toxicity.

Read the detailed description

EUCROSS is a phase II trial to evaluate the efficacy and safety of crizotinib in patients with adenocarcinoma of the lung harbouring ROS1 translocations. In individual treatment attempts and an ongoing phase I trial crizotinib has shown remarkable effects on this selected subgroup of lung cancer patients. Crizotinib is a tyrosine kinase inhibitor, blocking the catalytic activity of rearranged ALK and ROS1 as well as MET. The patients eligible for the trial will be treated with 250mg crizotinib twice-daily. Tumor response to treatment will be assessed every 6 weeks by CT or MRI scans. In case of progression treatment beyond may be conducted if clinically indicated. To identify mechanisms of resistance to crizotinib treatment, an optional re-biopsy may be performed in these cases and fresh frozen tumor material will analyzed at the University of Cologne.

Being tested
Crizotinib
Keywords
lung cancer, adenocarcinoma, NSCLC, ROS1, ROS1 translocation, crizotinib, phase II
Medical subject headings
Lung Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CrizotinibDrug

    Also called Xalkori

    250mg crizotinib bid until end of treatment

Study groups in NCT02183870
Study groupRoleWhat they receive
CrizotinibExperimentalPatients are treated in this single-arm trial with oral crizotinib 250 mg b.i.d.. Treatment dose will be adjusted according to the protocol if indicated. Treatment will be conducted until disease progression or beyond disease progression according to the protocol if clinically indicated.
Receives: Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR); evaluation criteria: investigator assessed RECIST v.1.1 analysis

    CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 fusion genes (primary outcome measure: objective response rate (ORR) according to RECIST v.1.1)

    Measured: From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) .

Secondary outcomes (9)

  1. Progression Free Survival (PFS) according to RECIST v1.1; evaluation criteria: investigator assessed RECIST v.1.1 analysis

    CT/MRI scans will be performed to assess the PFS during treatment period.

    Measured: From time of beginning of treatment until the first documented event of progression according to RECIST v1.1 (expected average 12 months).

  2. Overall Survival (OS); evaluation criteria: investigator assessed RECIST v.1.1 analysis

    OS will be assessed by telephone calls every 3 months after the safety follow-up visit.

    Measured: From beginning to end of study (Last subject last visit (LSLV)) (up to approximately 24 months).

  3. Duration of Response (DR); evaluation criteria: investigator assessed RECIST v.1.1 analysis

    CT/MRI scans will be performed to asses the DR.

    Measured: From time of beginning of treatment until the documention of progression according to RECIST v1.1 (expected average 12 months).

  4. Time to Tumor Response; evaluation criteria: investigator assessed RECIST v.1.1 analysis

    CT/MRI scans will be performed to assess the Time to Tumor Response.

    Measured: From time of beginning of treatment until the first documented event of response according to RECIST v1.1 (expected average 3 months).

  5. Disease Control Rate (DCR); evaluation criteria: investigator assessed RECIST v.1.1 analysis

    CT/MRI scans will be performed at weeks 6, 12, 24 to assess the DCR.

    Measured: From beginning of treatment to week 6, 12 and 24 according to RECIST v1.1 (expected average 3 months).

  6. Safety/Adverse Events and tolerability in all patients treated with crizotinib assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram and RECIST1.1

    Safety and tolerability will be assessed on every study visit and for 28 days after end of treatment.

    Measured: From beginning of treatment until 28 days post treatment (expected average 12 months).

  7. Patient Reported Outcomes (PRO) (EORTC QLQ-C30, EORTC QLQ-LC13)

    Patient reported outcomes (PRO) of health-related quality of life (HRQoL), disease/treatment related symptoms of lung cancer and general health status

    Measured: Questionnaires (EORTC QLQ-LC13, EORTC QLQ-C30) completed at baseline and every 4 weeks from beginning of treatment until end of study.

  8. To evaluate the efficacy of crizotinib treatment in the patient subgroup with ROS1 translocation confirmed by the CAGE technology regarding the objective response rate (ORR) (evaluation criteria: investigator assessed RECIST v1.1)

    CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment in advanced adenocarcinoma of the lung harbouring ROS1 fusion genes as confirmed by CAGE sequencing

    Measured: From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) .

  9. Objective Response Rate (ORR), Overall Survival (OS), Progression Free Survival (PFS), Duration of Response (DR), Time to Tumor Response, Disease Control Rate (DCR); evaluation criteria: RECIST v1.1 by independent radiologic review

    CT/MRI scans will be performed to evaluate the efficacy of crizotinib treatment

    Measured: From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion24 Jul 2018
  4. Study completion29 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02183870
Sponsor's protocol ID
EUCROSS
Other IDs
2013-002737-38, DRKS00005409
Acronym
EUCROSS
Status last verified
Jun 2022
First submitted
25 Jun 2014
Last updated
16 Jun 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Bos M, Gardizi M, Schildhaus HU, Heukamp LC, Geist T, Kaminsky B, Zander T, Nogova L, Scheffler M, Dietlein M, Kobe C, Holstein A, Maintz D, Buttner R, Wolf J. Complete metabolic response in a patient with repeatedly relapsed non-small cell lung cancer harboring ROS1 gene rearrangement after treatment with crizotinib. Lung Cancer. 2013 Jul;81(1):142-3. doi: 10.1016/j.lungcan.2013.02.018. Epub 2013 Apr 1.

    PubMed 23558310

  • Takeuchi K, Soda M, Togashi Y, Suzuki R, Sakata S, Hatano S, Asaka R, Hamanaka W, Ninomiya H, Uehara H, Lim Choi Y, Satoh Y, Okumura S, Nakagawa K, Mano H, Ishikawa Y. RET, ROS1 and ALK fusions in lung cancer. Nat Med. 2012 Feb 12;18(3):378-81. doi: 10.1038/nm.2658.

    PubMed 22327623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Crizotinib in people with Lung Cancer and Adenocarcinoma, run by University of Cologne at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR); evaluation criteria: investigator assessed RECIST v.1.1 analysis (time frame: From time of beginning of treatment until the documention of response according to RECIST v1.1 (expected average 12 months) .). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02183870, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.

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